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NCT06714266

Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Not yet recruiting Phase 2 Last updated 3 December 2024
What this trial tests

Phase 2 trial testing Trilaciclib in Head and Neck Squamous Cell Carcinoma (HNSCC) in 30 participants. Not yet recruiting.

Timeline
15 December 2024
Primary endpoint
31 August 2026
31 December 2026

Quick facts

Lead sponsorShandong Cancer Hospital and Institute
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment30
Start date15 December 2024
Primary completion31 August 2026
Estimated completion31 December 2026

Drugs / interventions tested

Conditions studied

Sponsor

Shandong Cancer Hospital and Institute

Who can join

18 and older, any sex, with Head and Neck Squamous Cell Carcinoma (HNSCC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This prospective, single-arm, exploratory, phase II study was designed to evaluate the efficacy and safety of Trilaciclib in reducing chemotherapy-induced neutropenia in patients with recurrent or metastatic head and neck squamous cell carcinoma. Eligible subjects screened by the inclusion and exclusion criteria will receive chemotherapy alone or combined with immune/targeted therapy and Trilaciclib for 4-6 cycles of continuous treatment. If the efficacy is not progressive after 4-6 cycles of treatment, the investigators can combine with Trilaciclib during immune and/or targeted maintenance therapy according to the specific conditions of the subjects until disease progression or intolerance. The efficacy of Trilaciclib will be evaluated by the incidence of grade ≥3 neutropenia during chemotherapy as the primary endpoint. After the progression of treatment, if the subjects were treated with chemotherapy for subsequent treatment and were considered to be able to use Trilaciclib according to the evaluation of the investigator, the use of treaclib could be considered until the subjects had disease progression again or were intolerant to treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Trilaciclib

Trials testing the same drug.

Other recruiting trials for Head and Neck Squamous Cell Carcinoma (HNSCC)

Currently open trials in the same condition.

Other Shandong Cancer Hospital and Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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